UroGen Pharma (URGN) said Wednesday the US Food and Drug Administration cleared its investigational new drug application for UGN-501, allowing the company to begin a phase 1 trial in patients with non-muscle invasive bladder cancer.
The company said patient enrollment in the phase 1 study is expected to begin in Q4 2026 and will evaluate the safety, tolerability and feasibility of intravesical administration of UGN-501.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.